临床试验/NCT01532180

NCT01532180已完成不适用

A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

ImThera Medical, Inc.2 个研究点分布在 1 个国家目标入组 14 人开始时间: 2009年11月最近更新: 2019年8月12日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: ImThera Medical, Inc.
入组人数: 14
试验地点: 2
主要终点: Adverse events and Serious Adverse events peri and post-operatively

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 25 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Moderate to severe obstructive sleep apnea (AHI 15 to 60).
•Cannot or will not tolerate CPAP treatment.
•Body mass index (BMI) between 25 and 40
•Able to read, understand, sign and date the written informed consent form

排除标准

未提供

研究组 & 干预措施

THN Therapy

Experimental

干预措施: aura6000 System (Device)

结局指标

主要结局

Adverse events and Serious Adverse events peri and post-operatively

时间窗: 3 and 12 months post-operative

Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.

时间窗: 3 and 12 months post-implant

次要结局

Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.(3 and 12 months post-implantation)
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.(3 and 12 months post-operative)

研究者

发起方

ImThera Medical, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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